Petition to revise GHR's FDA clearance On 26 October 1998, the US Food and Drug Administration (FDA)
reclassified electric tweezers like GHR, stating "there is
no statistically significant scientific data available at this
time to support promotional claims of permanent or long-term removal
of hair."
 FDA tweezer reclassification
(full text)
This left several questions regarding the status of two electric
tweezers, AHRS and GHR, which had claimed for many years to be
substantially equivalent to needle-type epilators.
On 19 May 1999, I submitted a petition to FDA asking them to
clarify their position and to rescind AHRS and GHR clearance as
substantially equivalent to needle epilators.
On 5 January 2000, FDA responded:
The initial classification of the AHRS
Epilator 629, as a needle-type epilator, was made in error.
We corrected this mistake shortly after we determined the device
to be substantially equivalent to a preamendment tweezer-type
epilator. We accomplished the correction by issuing a revised
order to the manufacturer that reflects the proper classification
of the device. Concerning
the GHR System, our records show that the device was not cleared
for marketing as a needle-type epilator, but was also cleared as a tweezer-type epilator.
Therefore, your request is based
on an erroneous assumption that these devices have been found
substantially equivalent to needle-type epilators.
On 11 February, I asked FDA to clarify comments made by reviewer
Paul Tilton in his review of GHR.
On 10 April 2000, FDA replied:
If there is any question as to which predicate device the product
was found equivalent, an examination of the clearance letter
dated August 5, 1991 that was sent to the company reveals that
the class of the device as originally cleared was class III.
This classification corresponds to the classification of the
Tweezer-Type Epilator. Therefore, this device was cleared
originally as a class III Tweezer-Type Epilator.
In other words, GHR was never considered by FDA to be substantially
equivalent to needle epilators.
You can download my petitions at FDA's website (warning: extremely
large .PDF files-- requires Adobe Acrobat):
Docket 99P-1615 (GHR petition)
Docket 99P-1614 (AHRS petition)
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